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SYS-054: VHP Sterilization Validation Procedure

Course

SYS-051: Software Tool Validation

Course

This software tool validation procedure includes the requirements for validating software tools in accordance with ISO/TR 80002-2:2017.

SYS-019: Post-Market Surveillance Procedure

Course

SYS-019 is our post-market surveillance procedure that meets the requirements for ISO 13485, the EU MDR, and SOR 98/282.

WI-008: Security Incident Response Planning

Course

This work instruction provides detailed instructions for a security incident response to a cybersecurity incident.

SYS-007: Customer-Related Processes Procedure

Course

The Customer-Related Processes Procedure defines the process for ensuring that customers’ requirements are met and transferred into your company operations.

SYS-006: Change Control Procedure

Course

This procedure explains the design change control process, including the decision regarding whether a new 510(k) submission is required for modifications to 510(k) cleared device.